After several years of relatively little enforcement, FDA has recently been flexing its muscles in the promotion area. The Office of Prescription Drug Promotion (OPDP) in particular has issued several notable warning and untitled letters in the past year, representing an increased volume in enforcement and increased scrutiny of efficacy claims. This includes more rigorous assessment of information “consistent with” FDA-required labeling (CFL) and enforcement of new expectations for presentation of quantitative efficacy information. Tune in to this overview session for an efficient rundown of what this means for drug, biological product, and device manufacturers in terms of key watchouts and practical approaches to risk mitigation.
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